This Study is a Non-randomized, Open-label, Multi-center Phase II Study of GW786034 to Evaluate the Administration of Oral GW786034 in Subjects With Ovarian Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Best Biochemical Response (Cancer Antigen [CA-125])
研究概览
简要总结
This study was designed to find out how effective and safe GW786034, is in the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pazopanib
800 mg GW786034 administered orally on a daily basis.
干预措施: GW786034 (Drug)
结局指标
主要结局
Best Biochemical Response (Cancer Antigen [CA-125])
时间窗: Baseline to response (up to 3 years)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response=≥50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 \>21U/mL) or non-normalized (CA-125≤1U/mL). Progressive disease (PD) =CA-125 increase ≥100% from nadir (nadir \>21U/mL) or ≥42U/mL (nadir ≤21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.
次要结局
- Overall Tumor Response(Baseline to response (up to 3 years))
- Time to Biochemical Response (CA-125)(Baseline to response (up to 3 years))
- Overall Response and Stable Disease (SD)(Baseline to response (up to 3 years))
- Duration of Biochemical Response (CA-125)(Baseline to response (up to 3 years))
- CA-125 Doubling Time Prior to and During Treatment With Pazopanib(Baseline to doubling of CA-125 (up to 3 years))
- Mean Change From Baseline to Response in Amylase and Lipase(Baseline to response (up to 3 years))
- Median Progression-free Survival (PFS)(Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years))
- Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Thyroid Stimulating Hormone(Baseline to response (up to 3 years))
- Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure(Baseline to response (up to 3 years))
- Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure(Baseline to response (up to 3 years))
- Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Albumin(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Total Bilirubin and Creatinine(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Thyroxine(Baseline to response (up to 3 years))
- Mean Change From Baseline to Response in Hemoglobin and Hematocrit(Baseline to response (up to 3 years))